Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

Basel, 16 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the Elecsys®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of hepatitis E virus (HEV) infections in countries accepting the CE mark. By testing for HEV infection, clinicians can support their patients to identify the cause of their symptoms and determine appropriate treatment, monitor for progression to severe acute HEV and prevent severe disease progression with antiviral treatment.1 ,2,6

Roche launches automated serology hepatitis E virus tests, including a test to detect acute HEV infections, recommended in the new WHO 2023 Essential Diagnostics List

Roche's (RHHBY) subcutaneous (SC) formulation of immuno-oncology drug Tecentriq gets CHMP's positive recommendation for all approved indications.

Roche (RHHBY) Tecentriq SC Receives Positive CHMP Opinion

Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin) Tecentriq® (atezolizumab). Tecentriq SC can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for intravenous (IV) infusion, which can free up time for patients, healthcare teams and caregivers.1 The CHMP recommended Tecentriq SC for all indications in which Tecentriq IV has been previously approved, including certain types of lung, liver, bladder and breast cancer.2 A final decision on its approval is expected from the European Commission in the near future.

Roche's subcutaneous injection of Tecentriq recommended by the EU's CHMP for multiple cancer types

Roivant Sciences Ltd

Roivant Sciences has reported a third-quarter earnings miss but revenue that topped analysts' expectations, sending its shares higher in Monday premarket trading. The company also said it has sufficient cash to fund its programs after it and Pfizer agreed to sell Telavant, manufacturer of an inflammatory bowel disease drug, to Roche for $7.25 billion.

Roivant cash-flush after $7.15B Telavant sale to Roche as it reports mixed 3Q

Biogen

Eli Lilly

There's now more than one medicine on the market to treat Alzheimer's disease. Safety and efficacy will be the two major areas of future competition.

The Alzheimer's Drug Market Is Heating Up. Should You Buy the Leading Contenders' Stocks?

Basel, 9 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys® Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The Elecsys NfL test is intended to be used as an aid in detection of disease activity in adults (18-55 years old) with Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS), providing critical insights for disease management.

Roche's Elecsys NfL test, an important aid for those living with Multiple Sclerosis, is granted FDA Breakthrough Device Designation

Monte Rosa Therapeutics

Monte Rosa Therapeutics is making progress in developing molecular glue degraders to target undruggable diseases. The company has released preliminary PK/PD data for its MGD MRT-2359, showing promising results in MYC-driven solid tumors. Monte Rosa entered into a partnership with Roche, $50 million upfront payment and potentially earning up to $2 billion in future milestone payments for MGDs against cancer and neurological indications.

Monte Rosa Therapeutics: Roche Partnership Deal Could Bring Added Value

Basel, 30 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today topline results from the global, randomised, double-blind Phase 3 EMBARK study of Elevidys™ (delandistrogene moxeparvovec) in ambulatory boys (those who can walk) with Duchenne muscular dystrophy aged 4-7 years. In the study, Elevidys-treated patients improved 2.6 points on their NSAA total score 52 weeks after treatment, compared to 1.9 points in placebo-treated patients (0.65; n=125; P=0.24).

[Ad hoc announcement pursuant to Art. 53 LR] Roche announces EMBARK trial in Duchenne muscular dystrophy (DMD) did not reach primary endpoint, but shows positive efficacy outcomes on all timed functional key endpoints

Pfizer

Roche spent $7.1 billion on a company, primarily because of an IBD therapy. Pfizer just got approval for a pill to treat ulcerative colitis.

Roche, Lilly or Pfizer: Who's the Winner in IBD Wars?

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Together, the three retinal conditions affect around 3 m.

FDA Approves Genentech's Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

Basel, 27 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (U.S. FDA) has approved Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication for Vabysmo, in addition to neovascular or ‘wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME).1 Together, the three retinal conditions affect around 70 million people worldwide and are among the leading causes of vision loss.2-5

[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche's Vabysmo for the treatment of retinal vein occlusion (RVO)

Roche's navify Digital Pathology software platform now offers Ibex's Artificial Intelligence (AI) algorithms to support clinicians in the diagnosis of breast and prostate cancer. Roche and Ibex cloud-based digital pathology and AI solutions run on Amazon Web Services (AWS), enabling a scalable and sustainable ecosystem for pathology laboratories.

Roche collaborates with Ibex and Amazon Web Services to accelerate adoption of AI-enabled digital pathology solutions to help improve cancer diagnoses

Roche acquired a bowel-disease treatment from Roivant for over $7 billion, the Wall Street Journal reported. Roivant made $5 billion from the sale, after having only spent $15 million on development. Pfizer originally passed it over to Roivant for free last December.

A biotech firm founded by Vivek Ramaswamy turned $15 million into $5 billion by flipping a bowel-disease treatment that Pfizer gave it for free

Swiss pharmaceutical company Roche has settled a patent lawsuit against U.S. biotech firm Biogen over its biosimilar version of Roche's blockbuster rheumatoid arthritis drug Actemra, according to a filing on Monday in Massachusetts federal court.

Roche settles US patent lawsuit against Biogen over blockbuster arthritis drug

London-based biotech firm Roivant Sciences (ROIV) agreed to sell its Telavant Holdings unit, which is co-owned by Pfizer (PFE), to Roche Holding for $7.1 billion.

Roivant Sciences Sells Joint Venture With Pfizer to Roche for $7.1 Billion

Roche said Monday it would buy an experimental immunology drug from Roivant and Pfizer for $7.1 billion, and ROIV stock rose.

Roche Follows Merck, Sanofi Into A Red-Hot Immunology Space With A $7.1 Billion Buyout

Shares of Roivant Sciences Ltd. ROIV, -1.13% and Pfizer Inc. PFE, -1.73% gained ground premarket on Monday after Roche Holding AG RHHBY, +0.51% agreed to buy immunology company Telavant for $7.1 billion.

Roivant, Pfizer shares rise as Roche agrees to buy immunology company for $7.1 billion

The Swiss pharma giant said it will begin late-stage trials on the experimental antibody therapy “as soon as possible” to help bring it to patients suffering from inflammatory bowel disease.

Roche Secures Promising Bowel Disease Therapy—Which Could Help Treat Crohn's—In $7.1 Billion Telavant Deal

The deal is the latest example of a big pharma company turning to the deal table to bolster its pipeline of autoimmune drugs.

Roche to Buy Bowel-Disease Drug From Roivant, Pfizer for More Than $7 Billion

It will buy immunology company Telavant Holdings from Roivant Sciences and Pfizer.

Roche Agrees $7.1 Billion for Drug Company

Roche has agreed to pay US$7.1 billion for an early-stage inflammatory bowel disease treatment developed by US rivals Roivant and Pfizer. For its money, the Swiss group will get the rights to develop, manufacture and commercialise the experimental drug known as RVT-3101 in the US and Japan.

Roche splashes US$7.1 billion on new irritable bowel drug

Swiss health care company Roche announced it would acquire Telavant Holdings Monday, in a deal worth $7.1 billion.

Swiss pharma giant Roche agrees $7.1 billion deal to buy Telavant Holdings

Roche on Monday said it will buy Telavant, a developer of a new treatment for inflamatory bowel diseases, for an initial $7.1 billion from American biopharma company Roivant Holdings and Pfizer Inc.

Roche buys Telavant Holdings for $7.1 billion

Basel, 23 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the entry into a definitive agreement to acquire Telavant Holdings, Inc. (Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc.. The agreement includes the development, manufacturing and commercialisation rights in the US and Japan for Televant's RVT-3101, a novel TL1A directed antibody. RVT-3101 is a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn's disease. Inflammatory bowel disease is a group of chronic gastrointestinal disorders with almost 8 million people diagnosed worldwide and 80% of all individuals not experiencing lasting remission.1 Given the antibody's novel mode of action targeting both inflammation and fibrosis, it has potential to be applied in multiple other diseases.

[Ad hoc announcement pursuant to Art. 53 LR] Roche enters into a definitive agreement to acquire Telavant including rights to novel TL1A directed antibody (RVT-3101) for the treatment of inflammatory bowel disease from Roivant

Pfizer's revenue has taken a big hit because of lower COVID-19-related sales. Roche just released third-quarter earnings.

News for Roche Holding AG Stock (RHHBY)